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COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry


N/A
18 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry


A non-probability sampling method will be used. Subjects will be requested to enroll in the
registry after having completed or discontinued participation in a Phase 2 or 3 study
involving vicriviroc.


Inclusion Criteria:



- Subjects must have participated in a Phase 2 or 3 study involving vicriviroc, and
must have received, but are no longer receiving study medication.

Exclusion Criteria:

- Unwillingness to participate in the registry or give informed consent.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Incidence of malignancies, AIDS-defining events, other clinical events of importance, and death.

Outcome Time Frame:

Information regarding clinical outcome will be collected every 6 months. Deaths will be collected on an ongoing basis.

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

P04999

NCT ID:

NCT00705419

Start Date:

July 2007

Completion Date:

September 2010

Related Keywords:

  • HIV Infections
  • Treatment Experienced
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

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